MAUDE Adverse Event Report: STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C

Catalog Number UNK_JR

Device Problem Crack (1135)

Patient Problem Injury (2348)

Event Date 05/27/2019

Event Type  Injury  

Manufacturer Narrative

A review of the device history records indicate that devices were manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.If additional information is received, it will be provided in a supplemental report upon completion of the investigation.Device not available.

Event Description

It was reported that a patient underwent a revision surgery due to fracture.The patient had an original implant in 2013, which was revised in (b)(6) 2017.This fractured again in (b)(6) 2019 and this pi is for the operation carried last week.

Manufacturer Narrative

An event regarding crack/fracture involving an unknown mrh femoral component was reported. the event was confirmed based on evaluation of the returned device.Method & results:  device evaluation and results: visual inspection confirmed that the lateral condyle was returned fractured from the femoral component.Material analysis concluded that the fractured femoral component exhibited evidence of fatigue striations consistent with fatigue fracture.The damage observed on the rotating tibial component and femoral component is consistent with impingement.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.Clinician review: no medical records were received for review with a clinical consultant.   device history review: could not be performed as lot code information was not provided and the lot id is not visible on the returned device.  complaint history review: could not be performed as lot code information was not provided.  conclusion:  visual inspection confirmed that the lateral condyle was returned fractured from the femoral component.Material analysis concluded that the fractured femoral component exhibited evidence of fatigue striations consistent with fatigue fracture.The damage observed on the rotating tibial component and femoral component is consistent with impingement.Based on the given information, no identifiable material or manufacturing discrepancies were observed on the surfaces examined.The exact cause of the event could not be determined because insufficient information was provided. additional information including device details, operative reports, progress notes and x-rays are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.

Event Description

It was reported that a patient underwent a revision surgery due to fracture.The patient had an original implant in 2013, which was revised in (b)(6) 2017.This fractured again in (b)(6) 2019 and this pi is for the operation carried last week.

• Brand Name: UNKNOWN FEMORAL COMPONENT
• Type of Device: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
• Manufacturer (Section D): STRYKER ORTHOPAEDICS-MAHWAH; 325 corporate drive; mahwah NJ 07430
• MDR Report Key: 8964569
• MDR Text Key: 156584396
• Report Number: 0002249697-2019-03082
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_JR
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 21 YR
• Patient Weight: 72